Health Canada adopts new approach for in vitro dissolution data for additional strength biowaivers: Notice
Effective date: October 29, 2026
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Background
The International Council for Harmonisation (ICH) adopted a guideline, known as M13B, for additional strength biowaivers on August 4, 2026.
We're in the process of revising the in vitro dissolution requirements in our guidance to align with the ICH guideline. In the interim, during the review of a submission seeking an additional strength biowaiver, we may ask the sponsor to provide additional in vitro dissolution data.
Section C.08.004 of the Food and Drug Regulations gives us the authority to require additional information or material when necessary to assess the safety, efficacy or quality of a drug submission.
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What we're doing
Requesting additional in vitro dissolution data during a review reflects current international scientific standards.
The regulatory requirement for a biowaiver request remains unchanged. Sponsors will still be responsible for filing submissions that contain enough information to support the safety, efficacy and quality of their drug product. Our request for additional data will only be made to support a regulatory decision.
Our new approach may help:
- make the regulatory process more efficient
- support timely decisions in line with established performance standards
- provide sponsors with flexibility to address dissolution information, where appropriate
- streamline the review of additional strength biowaiver requests when additional dissolution information is needed
This approach takes effect as of the date of this notice.
How the new approach works
We may ask for additional in vitro dissolution data to help us assess an additional strength biowaiver during the review of your submission.
The information you submit must address the issues we identify. You can't use this opportunity to make major changes to your submission, such as adding a new indication or a new route of administration. You would have to file a new submission or supplement, whichever is applicable, if you wish to make major changes.
Note that submission requirements under the regulations, existing review processes and pause-the-clock provisions will continue to apply.